The U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) investigating a potential new indication to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes, Boehringer Ingelheim and Eli Lilly announced.
The sNDA is based on the results from the DINAMO phase III trial, in which Jardiance was associated with a statistically significant reduction in the primary endpoint of change from baseline in A1c at 26 weeks compared with placebo in participants aged 10-17 years with type 2 diabetes. When added to other baseline treatments (diet, exercise, metformin and/or insulin), Jardiance 10 mg and 25 mg pooled doses reduced A1c by 0.84% compared with placebo at week 26 (95% CI −1.50 to −0.19; P=0.012). Reduction in A1c in participants treated with Tradjenta® (linagliptin) was not statistically significant when compared with placebo. A numerical reduction of 0.34% (P=0.2935) was observed. Results were presented during the International Diabetes Federation World Diabetes Congress 2022.
Overall, the safety data in DINAMO was consistent with the previously known safety profile of Jardiance.
Initially approved in 2014, Jardiance is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes; and to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease. Jardiance is also indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. Jardiance is not for patients with type 1 diabetes, or to improve glycemic control in adults with type 2 diabetes with an eGFR <30 mL/min/1.73 m2. Jardiance is contraindicated in people with hypersensitivity to empagliflozin or any of the excipients in Jardiance, and in patients on dialysis.